Topical Infliximab in Eyes With Penetrating Keratoplasty
Recruiting
Phase 1Phase 2Interventional Study
Glaucoma Following Surgery
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Prevention
Participants needed
50 (estimated)
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM) · Other
Who this trial is looking for
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Answer a few quick questions to see if you may meet the eligibility requirements.
Penetrating keratoplasty is a cornea surgery involving several inflammatory complications, of which the most important is glaucoma. Researchers wish to determine whether it is safe to administer infliximab (an anti-inflammatory drug) eye drops after surgery, and whether this eye drop could prevent the occurrence of glaucoma.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age between 18 and 80 years;
* First corneal transplant surgery;
* Capable of providing informed consent;
* Capable of administering eye medication or access to a caregiver able and willing to administer the eye medication for the patient.
Exclusion Criteria:
* Active ocular…
Inclusion Criteria:
* Age between 18 and 80 years;
* First corneal transplant surgery;
* Capable of providing informed consent;
* Capable of administering eye medication or access to a caregiver able and willing to administer the eye medication for the patient.
Exclusion Criteria:
* Active ocular infection;
* Past corneal transplant (any technique);
* Advanced glaucoma or macular disease;
* Active or latent systemic infection (tuberculosis, histoplasmosis, coccidioidomycosis, cytomegalovirus, pneumocystis, aspergillosis or hepatitis B);
* Malignancy diagnosed in the past 5 years (any kind);
* Demyelinating disease;
* History or current diabetes mellitus (controlled or uncontrolled) or heart failure (New York Heart Association class III or IV);
* Pregnancy or breastfeeding;
* Allergy to infliximab or to a compound of its topical formulation;
* Significant anomaly of complete blood count or hepatic enzymes;
* Current or anterior use of anti-TNF-α medication or other anti-inflammatory biologics.
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